PE-1 in the Diagnosis of Pancreatic Exocrine Insufficiency

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Fecal pancreatic elastase 1 test

About this trial

This is an interventional diagnostic trial for Pancreatic Exocrine Insufficiency focused on measuring PE-1, Pancreatic exocrine insufficiency

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: - 【patients with clinical diagnosed PEI】 Inpatients or outpatients of both sexes, aged 18 to 80 years. Patients with pancreatic disease or after pancreatic or gastric resection (one of the following) Chronic pancreatitis. At least 3 months after pancreatectomy (surgical procedures included total pancreatectomy, pancreaticoduodenectomy, pylorus-preserving pancreaticoduodenectomy, and distal pancreatectomy). Patients recovering from severe acute pancreatitis (duration less than 24 months). More than 3 months after gastrectomy (surgical methods included total gastrectomy, proximal gastrectomy, and distal gastrectomy). Enrolled patients had at least one of the following symptoms (except those after pancreatectomy) abdominal distension. Weight loss (weight loss is defined as loss of more than 5% of basal body weight in one year). steatorrhea. Agreed to participate in the study and signed an informed consent form. 【patients without clinical diagnosed PEI】 Both male and female, aged between 18 and 80 years old. Patients who met one of the following criteria were included in the study: Patients with functional gastrointestinal diseases who had no history of pancreatectomy, gastrectomy, or abdominal radiotherapy were included. Healthy volunteers. Patients with benign hepatobiliary diseases, thyroid, breast diseases, and digestive tract diseases who had no history of pancreatectomy, gastrectomy, or abdominal radiotherapy were included. Agreed to participate in the study and signed an informed consent form. Exclusion Criteria: Pregnant women Critically ill patients The subjects with mental disorders were unable to cooperate with the researchers patients who had undergone ileocolon bladder replacement surgery or complicated with intestinal obstruction and other diseases that could not collect feces the quantity of fecal samples, storage and transportation conditions of samples do not meet the requirements of the kit patients who underwent two or more times of gastrectomy or pancreatectomy

Sites / Locations

Changhai Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pancreatic exocrine function

Arm Description

Strict clinical diagnosis and fecal pancreatic elastase 1 test were performed for each subject (including PEI patients (n=525) and non-PEI patients (n=528))

Outcomes

Primary Outcome Measures

Reliability of fecal pancreatic elastase 1 test in the diagnosis of PEI

Diagnostic consistency (kappa value) of fecal pancreatic elastase 1 test

Secondary Outcome Measures

Accuracy of fecal pancreatic elastase 1 test in the diagnosis of PEI

Diagnostic sensitivity, specificity, positive likelihood ratio, negative likelihood ratio of fecal pancreatic elastase 1 test

Predictive value of fecal pancreatic elastase 1 test in the diagnosis of PEI

Positive predictive value, negative predictive value of fecal pancreatic elastase 1 test

Accuracy, reliability, and predictive of fecal pancreatic elastase 1 test in the diagnosis of severe PEI

Severe PEI was defined as PE-1 content in feces less than 100μg/g. Diagnostic consistency (kappa value), sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, positive predictive value, negative predictive value of fecal pancreatic elastase 1 test in severe PEI.

Full Information

NCT ID

NCT05791110

First Posted

March 17, 2023

Last Updated

April 11, 2023

Sponsor

Changhai Hospital

Collaborators

Xuanwu Hospital, Beijing, Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05791110

Brief Title

PE-1 in the Diagnosis of Pancreatic Exocrine Insufficiency

Official Title

Diagnostic Value of Fecal Pancreatic Elastase 1 in the Diagnosis of Pancreatic Exocrine Insufficiency: a Multi-center Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

July 30, 2020 (Actual)

Primary Completion Date

May 30, 2021 (Actual)

Study Completion Date

August 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changhai Hospital

Collaborators

Xuanwu Hospital, Beijing, Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

The aim of this study was to evaluate and determine the clinical performance of Fecal Pancreatic Elastase 1 Test in the diagnosis of pancreatic exocrine insufficiency.

Detailed Description

Fecal Pancreatic Elastase 1 (PE-1)Test has high diagnostic accuracy in pancreatic exocrine insufficiency (PEI), has become a painless noninvasive diagnostic modality in clinical practice, and has been widely used in clinical practice. However, in China, the diagnostic ability of the PE-1 test in the Chinese population has not been demonstrated and has not been reported. Meanwhile, pancreatin stimulation, 13C-mixed triglyceride breath test, and N-benzoyl-L-tyrosyl-p-aminobenzoic acid test required drugs, which cannot pass the examination of the drug administration and were not allowed to be carried out to diagnose PEI in China. In addition pancreatin stimulation is an invasive test has certain risks for subjects and 72-hour fecal fat quantification was mainly used for the diagnosis of severe PEI. Therefore, This study adopted strict clinical diagnosis as a comparative method for PE-1 test to judge the ability of PE-1 test to diagnose PEI in the Chinese population. This study aims to clarify the application efficacy of PE-1 test in PEI through a multi-center, prospective clinical study comparing PE-1 test with strict clinical diagnosis. To study the accuracy of PE-1 test in the diagnosis of PEI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Exocrine Insufficiency

Keywords

PE-1, Pancreatic exocrine insufficiency

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1053 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pancreatic exocrine function

Arm Type

Other

Arm Description

Strict clinical diagnosis and fecal pancreatic elastase 1 test were performed for each subject (including PEI patients (n=525) and non-PEI patients (n=528))

Intervention Type

Diagnostic Test

Intervention Name(s)

Fecal pancreatic elastase 1 test

Intervention Description

Fecal pancreatic elastase 1 test are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.

Primary Outcome Measure Information:

Title

Reliability of fecal pancreatic elastase 1 test in the diagnosis of PEI

Description

Diagnostic consistency (kappa value) of fecal pancreatic elastase 1 test

Time Frame

1 week

Secondary Outcome Measure Information:

Title

Accuracy of fecal pancreatic elastase 1 test in the diagnosis of PEI

Description

Diagnostic sensitivity, specificity, positive likelihood ratio, negative likelihood ratio of fecal pancreatic elastase 1 test

Time Frame

1 week

Title

Predictive value of fecal pancreatic elastase 1 test in the diagnosis of PEI

Description

Positive predictive value, negative predictive value of fecal pancreatic elastase 1 test

Time Frame

1 week

Title

Accuracy, reliability, and predictive of fecal pancreatic elastase 1 test in the diagnosis of severe PEI

Description

Severe PEI was defined as PE-1 content in feces less than 100μg/g. Diagnostic consistency (kappa value), sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, positive predictive value, negative predictive value of fecal pancreatic elastase 1 test in severe PEI.

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - 【patients with clinical diagnosed PEI】 Inpatients or outpatients of both sexes, aged 18 to 80 years. Patients with pancreatic disease or after pancreatic or gastric resection (one of the following) Chronic pancreatitis. At least 3 months after pancreatectomy (surgical procedures included total pancreatectomy, pancreaticoduodenectomy, pylorus-preserving pancreaticoduodenectomy, and distal pancreatectomy). Patients recovering from severe acute pancreatitis (duration less than 24 months). More than 3 months after gastrectomy (surgical methods included total gastrectomy, proximal gastrectomy, and distal gastrectomy). Enrolled patients had at least one of the following symptoms (except those after pancreatectomy) abdominal distension. Weight loss (weight loss is defined as loss of more than 5% of basal body weight in one year). steatorrhea. Agreed to participate in the study and signed an informed consent form. 【patients without clinical diagnosed PEI】 Both male and female, aged between 18 and 80 years old. Patients who met one of the following criteria were included in the study: Patients with functional gastrointestinal diseases who had no history of pancreatectomy, gastrectomy, or abdominal radiotherapy were included. Healthy volunteers. Patients with benign hepatobiliary diseases, thyroid, breast diseases, and digestive tract diseases who had no history of pancreatectomy, gastrectomy, or abdominal radiotherapy were included. Agreed to participate in the study and signed an informed consent form. Exclusion Criteria: Pregnant women Critically ill patients The subjects with mental disorders were unable to cooperate with the researchers patients who had undergone ileocolon bladder replacement surgery or complicated with intestinal obstruction and other diseases that could not collect feces the quantity of fecal samples, storage and transportation conditions of samples do not meet the requirements of the kit patients who underwent two or more times of gastrectomy or pancreatectomy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

zhuan liao

Organizational Affiliation

Changhai Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Changhai Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200433

Country

China

12. IPD Sharing Statement

Plan to Share IPD

No

Pancreatic Exocrine Insufficiency

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial